A population of 190 women who refer to Gynecology Clinic will be investigated in this clinical trial after being informed and signing the written consent. The subjects' eligibility for this research will be examined by screening the PH of their vaginal discharge, laboratory analysis of vaginal discharge slides for detection of vaginosis bacterial, and measurement of Vitamin D concentration in blood sample serum. Subjects passing the history, clinical and lab tests will take part in random phase and will be blindly divided in two groups: intervention and control (researcher, research unit and statistician will not be informed). For intervention group, daily drops of 2000-unit vitamin D3 dissolved in sesame oil and for the control group, placebo (sesame oil only) with the same appearance, color, taste and smell of intervention group will be advised for 15 weeks (105 days/3.5 months). At the end of the intervention, bacterial vaginosis and vitamin D concentration will be evaluated in samples.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105096284N2
Registration date:2011-09-04, 1390/06/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-04, 1390/06/13
Registrant information
Name
Maryam Modarres
Name of organization / entity
Tehran university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 8142
Email address
modarres@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2012-01-20, 1390/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effectiveness of oral vitamin D3 on Bacterial vaginosis in women in fertility ages
Public title
Assessment of effectiveness of oral vitamin D3 on Bacterial vaginosis in women in fertility ages
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Ages 18-35; Stability in medical condition among 6 months later; Lack of Pathological obesity; Not using tobacco; Lack of history of hypercalcemia, nephrolitiasis or sarcoidosis; Lack of current pregnancy; Lack of recent history of hospitalization; Absence of liver or kidney disorder; current malignancy or malabsorption; Lack of immune suppression, or those drugs that will interfere with vitamin D metabolism, such as phenytoin and carbamazepine; Not taking vitamin D supplements meet; Lack of clinical bacterial vaginosis; Lack of normal amounts of vitamin D in first assessment; Detection of asymptomatic bacterial vaginosis with nugent test
Exclusion criteria: Unwillingness to continue the use of drug; pregnancy occurred; Drug allergy symptoms such as gastrointestinal symptoms; Vaginal infection symptoms like foul-smelling discharge; Use of drug non according to the pharmacist recommendation
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical sciences
Street address
f 6th, Center organization of university, edge of Qods avenue, Keshavarz blvd
City
Tehran
Postal code
Approval date
2011-06-19, 1390/03/29
Ethics committee reference number
130/1312/د
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitis
Primary outcomes
1
Description
Bacterial vaginosis
Timepoint
105 days
Method of measurement
Nugent test
Secondary outcomes
1
Description
Concentration of vitamin D in serum
Timepoint
105 days
Method of measurement
Lab test
Intervention groups
1
Description
Placebo drops of Sesame oil only, with the shape, taste, color & smell as same as intervention group which is prescribed 2 drops per day for 105 days
Category
Placebo
2
Description
Oral drops of vitamin D3 which is prescribed Two drops (2000 IU vitamin D) per day for 105 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital gynecology Clinic
Full name of responsible person
Mahshid Taheri
Street address
Gynecology clinic, Hospital complex of Imam Khomeini, Tohid square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical sciences
Full name of responsible person
Research assistant of Tehran University of Medical sciences (Dr. Akbar Fotoohi)
Street address
5th floor,Central building of Tehran University of Medical sciences, edge of Qods Av, Keshavarz blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Dr. Masud Yunesian
Position
Research Affairs
Other areas of specialty/work
Street address
601th Unit, 6th floor, Central Organization of Tehran University of Medical sciences, Qods ave, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 8163 3619
Fax
Email
younesian@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery
Full name of responsible person
Maryam Modarres
Position
MSc Midwifery
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Tohid square
City
Tehran
Postal code
Phone
+98 912 388 0257
Fax
Email
modarres@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)